CI665: Navigating the IRB

Assistant Professor | School of Information Science

Dr. T. Kody Frey

What do I know?

  • E-IRB Application Overhaul V4 Reviewer
  • Responsible Conduct of Research In-Person Trainer
  • Frequent ORI Zoom Office Hours Attendee
  • Protocol Violation Delinquent
  • Occasional pain in the IRB’s side

Disclaimer

  • Tried to make this super practical
  • Work on getting your protocols started as we go.
  • My goal is to help you submit a protocol and respond to feedback.

What is the IRB?

  • Your friend!
  • Your enemy.
  • An ethics committee

What does the IRB do?

  • Formally review, approve, and monitor human subjects research to ensure the safety, rights, and welfare of subjects are protected
  • Determine the degree and likelihood of risk

Abandon Your Present Biases

Are communication studies risky?

Minimal risk:

“the probability and magnitude of harm or discomfort anticipated … are not greater … than those ordinarily encountered in daily life or during … routine physical or psychological examinations or tests.”

What Can I Share That Might Help You?

The 3 Ps!

  • The Process
  • The Parts
  • The Person

The Process

I want to answer 3 questions in this section:

  • How do I get started?
  • What do I need to actually include?
  • How do I submit it?

How do I get started?

The good thing is that the whole process is electronic.

Starting Your Protocol

Let’s build a new application.

Understanding the system

It looks more complicated than it is - try not to let it intimidate you

Pay attention to the ‘All Templates’ button in the top left

Getting through it unscathed

  • Save. Save. Save. Save. Save.
  • Utilize the templates
  • Give yourself time
  • Ask for help
  • Do not expect your initial submission to be approved
  • Be thorough
  • Use Don’s feedback

Don’s Feedback!

Before you can actually submit your protocol to the IRB, it must be reviewed by the Associate Dean for Research (Don)

Don’s Feedback!

After all information is entered, you send it to Don for feedback

In any case, email to 1) thank for feedback and 2) explain your changes.

The Parts

Looking closer at the protocol, here is what you can expect to complete:

  • Protocol Type
  • Exemption Category
  • Project Info
  • Subject Demographics
  • Informed Consent/Assent Process/Waiver
  • Research Description
  • Additional Info
  • Signatures

Are we going to cover all that?

No.

Let’s focus primarily on 2 parts:

Using the Template(s)

  • The tell you exactly how to set it up for approval.
  • Use same language from existing or example protocols but do not copy.
  • Keep it simple.

Preparing your Research Description

  • Be consistent but avoid repeating
  • Save. Save. Save. Save. Save.
  • Have everything ready
    • Survey Instruments or Experimental Materials (at least scripted)
    • Emails to potential participants / listservs / contacts
    • Supplemental materials (handouts, instructions, etc.)

If you want to add it later, you will have to submit a modification request

Preparing your Research Description

Preparing your Research Description

  • I like to look at example protocols for inspiration. If they have been approved before, you know what language works.
  • People are happy to share!

Did you Violate Your Protocol?

Submit a Modification Request (MR) when:

  • You need more data
  • You changed or added more questions to a survey or schedule
  • Your messaging has changed in some way

Why I’m a Delinguent

  • Written up for broken protocol
  • No formal consequences
  • Allow me to explain…

The Person

  • Most communication research is likely reviewed by just one person unless there is risk.
  • I’ve had the same guy for every project I’ve submitted to the ORI at UK.
  • We are now friends.

When Do I Hear From Them?

After you incorporate Don’s feedback and submit, one of two things will happen”

  • You will get IRB feedback likely in 2-3 weeks
  • You will get an email saying that it has been screen and needs changes before going to the IRB.

The odds that it gets accepted right away are slim.

How Do I Deal with the Person?

  • Try not to take it personally
  • Give them what they want
  • Contact them directly
  • Make sure they know you aren’t taking it personally
  • Make them feel like you are serious about the ORI
  • Be super specific and thorough
  • Respond to everything!

Example Responses

Example Responses

Building the Relationship

  • They appreciate questions because it makes their work easier
  • Consider Zoom office hours
  • Call them up!
  • Be nice. How would you want to be treated?

They want you to get approved.

Questions???

Source code for presentation available via Github: tkodyfrey/IRB_Talk

| @TKFrey | tkodyfrey.github.io